Comparing doravirine and dolutegravir for treating HIV-1 in new patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III clinical trial evaluates the effectiveness of doravirine combined with tenofovir and lamivudine against dolutegravir with either tenofovir and lamivudine or emtricitabine in treatment-naïve individuals living with HIV-1. The study is multicenter, open-label, and randomized, aiming to determine if doravirine is non-inferior to dolutegravir in achieving viral suppression. A total of 610 participants will be enrolled and monitored for 96 weeks, with the primary endpoint focusing on the proportion of patients achieving an HIV-1 RNA level of less than 50 copies/mL at Week 48.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be at least 18 years of age on the day of signing the informed consent.
* Be HIV-1 positive as determined according to national testing strategies
* Have a plasma HIV-1 RNA ≥1000 copies/mL within 30 days prior to the randomization,
* Have HIV treatment indication based on physician assessment according to local treatment guidelines
* Be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents
* For women or transgender men of childbearing potential i.e. of childbearing age who are not menopausal, or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) or not refraining from sexual activity: negative urinary test for pregnancy and acceptance to use contraceptive methods
* Understand the study procedures and voluntarily agree to participate by giving written informed consent for the trial.

Non-inclusion Criteria:

* Has ongoing (pulmonary or extra-pulmonary) tuberculosis
* Has any other history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
* Is infected with HIV-2 or co-infected with HIV-1 and HIV-2
* Has received cabotegravir long acting or dapivirine pre-exposure prophylaxis (PrEP).
* Has received oral pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) in the past three months or has had no negative HIV-1 serology performed
* Has documented or known resistance or possible resistance to study drugs (in France and where national guidelines recommend screening for primary resistance before starting first-line ART) as defined by the ANRS MIE AC43 Resistance group
* Has the following laboratory values at screening visit, within 30 days prior to the randomization:

  * AST (SGOT) and ALT (SGPT) \>4.0 x upper limit of normal
  * Estimated glomerular filtration rate at time of screening \<60 mL/min/1.73m², based on the CKD-EPI equation
* Has participated in a study with an investigational compound/device within 30 days prior to signing informed consent or anticipates participating in such a study involving an investigational compound/device during the course of this study.
* Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study
* Requires or is anticipated to require any of the prohibited or contraindicated medications noted in the trial protocol.
* Has significant hypersensitivity or other contraindication to any of the components of the study drugs.
* Is pregnant, breastfeeding, or expecting to conceive at any time during the study.
* Has any condition which might, in the investigator's opinion, compromise the safety of treatment and/or patient's adherence to study procedure.
* Is a person under guardianship or deprived of freedom by a judicial or administrative decision

Where it's running

• Hospital Geral de Nova Iguaçu
  Nova Iguaçu, Rio de Janeiro, Brazil Recruiting
• Laboratory on Clinical research on AIDS-INI FIOCRUZ
  Rio de Janeiro, Rio de Janeiro, Brazil Recruiting
• Hôpital Central de Yaoundé
  Yaoundé, Cameroon Recruiting
• Centre de prise en charge de Recherche et de Formation (CEPREF)
  Abidjan, Côte d’Ivoire Recruiting
• CHU de Treichville, Service des Maladies Infectieuses et Tropicales (SMIT)
  Abidjan, Côte d’Ivoire Recruiting
• CHU Bordeaux Pellegrin - Service des Maladies Infectieuses et Tropicales
  Bordeaux, France Recruiting

Study contacts

• Principal investigator: Pierre SELLIER, Dr — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Boris TCHAKOUNTE YOUNGUI, Dr
• Email: boris.tchakounte@u-bordeaux.fr
• Phone: 33 (0)5 57 57 47 11

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Restarting HIV treatment with a single-pill regimen (B/F/TAF) after a treatment gap

  This study tests whether quickly restarting ART with the single-pill regimen B/F/TAF is safe and effective for people with HIV who have had a treatment interruption of at least 12 weeks.

  Recruiting at 10 sites Phase 4 CAN Community Health · Clearwater, Florida and 9 other locations · NCT07476339

• Weekly long-acting HIV-1 meds switch for people with undetectable virus

  This study tests whether switching to weekly oral long-acting HIV medicines works as well as staying on current daily pills for people with HIV who already have an undetectable viral load.

  Recruiting at 2 sites Phase 2 Gilead Sciences · Ft. Pierce, Florida and 1 other locations · NCT07841990

• HIV in Hong Kong: patterns, transmission, and burden over time

  This project tests how HIV-1 infections in Hong Kong have changed over several years by following newly diagnosed adults and analyzing their subtypes, transmission links, and community burden.

  Recruiting Chinese University of Hong Kong · North Point · NCT07725042

• GS-0415 safety and PK in people with HIV on ART

  This study tests GS-0415 in adults with HIV who are on stable ART to see if it is safe, tolerable, and how the drug behaves in the body.

  Recruiting at 15 sites Phase 1 Gilead Sciences · Los Angeles, California and 15 other locations · NCT07719491

• Gilead study of GS-3242 with Lenacapavir for people starting HIV treatment compared with Biktarvy

  This study tests whether injecting GS-3242 with Lenacapavir can work as well as Biktarvy for people newly starting HIV treatment.

  Recruiting at 19 sites Phase 2/3 Gilead Sciences · Torrance, California and 20 other locations · NCT07708727

• RNA-based vaccine BNT168 safety and immune response in adults with or without HIV

  A first-in-human study tests whether the RNA vaccine BNT168 is safe and can trigger immune responses in adults both with and without HIV.

  Recruiting at 3 sites Phase 1 BioNTech SE · Houston, Texas and 3 other locations · NCT07698600

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.